Memo
Re Bharat Biotech Covaxin.
1. We have a rregulatory approval process that approves vaccines on the basis of data demonstrating safety and efficacy.
2. The trustworthiness of this process is shown when approval is NOT granted in the absence of such data.
Re Bharat Biotech Covaxin.
1. We have a rregulatory approval process that approves vaccines on the basis of data demonstrating safety and efficacy.
2. The trustworthiness of this process is shown when approval is NOT granted in the absence of such data.
Memo (continued)
3. We trust a licensed vaccine not because it has been approved by the regulator.
We trust it when the regulator and the manufacturer are open and transparent with the data on which the approval is based.
3. We trust a licensed vaccine not because it has been approved by the regulator.
We trust it when the regulator and the manufacturer are open and transparent with the data on which the approval is based.
4. We should no more accept an opaque regulatory process that we would accept a kangaroo court that delivers its verdict in a closed court.
We must not confuse between cause and effect, any more than we should interchange cart and horse.
A vaccine does not become trustworthy because it has been approved.
A vaccine is approved because it has proved its trustworthiness in clinical trials
A vaccine does not become trustworthy because it has been approved.
A vaccine is approved because it has proved its trustworthiness in clinical trials
About #BharatBiotech and #Covaxin
Did you know?
that BBL is seeking to take its Covaxin to the US Market. It has enetered into a licensing deal with US company Ocugen (Chairman and CEO Dr Shankar Musunuri) to carry out clinical trials and win FDA approval.
Did you know?
that BBL is seeking to take its Covaxin to the US Market. It has enetered into a licensing deal with US company Ocugen (Chairman and CEO Dr Shankar Musunuri) to carry out clinical trials and win FDA approval.
Musunuri stated, "We have been very pleased with the safety and immunogenicity demonstrated by the Phase 1 and Phase 2 trials of COVAXIN™ and are encouraged
with the progress of the Phase 3 trials in India." So someone has seen the Phase 2 trial results. Where are they?
with the progress of the Phase 3 trials in India." So someone has seen the Phase 2 trial results. Where are they?
Source of Information: Bharat Biotech Limited Press release. Read it here:
bharatbiotech.com/images/press/b…
bharatbiotech.com/images/press/b…
Thanks to @PriyankaPulla who has pouinte me in the direction of the Phase 2 write up on @medrxivpreprint . It was published on 22 Dec 2020 and the link is here: medrxiv.org/content/10.110…
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